Furosemide Bristol 40 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Furosemide

Available from:

Brillpharma (Ireland) Limited

ATC code:

C03CA; C03CA01

INN (International Name):

Furosemide

Dosage:

40 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

Sulfonamides, plain; furosemide

Authorization status:

Marketed

Authorization date:

2006-05-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FUROSEMIDE 20MG TABLETS
FUROSEMIDE 40MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm
them, even if their signs of illness are same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet
WHAT IS IN THIS LEAFLET:
1. What Furosemide Tablets are and what they are used for
2. What you need to know before you take Furosemide Tablets
3. How to take Furosemide Tablets
4. Possible Side Effects
5. How to store Furosemide Tablets
6. Contents of the pack and other information
1. WHAT FUROSEMIDE TABLETS ARE AND WHAT THEY ARE USED FOR
Furosemide belongs to a group of medicines called diuretics, which
increase the amount of
urine passed by the kidneys, helping to remove excess fluids from the
body. Diuretics are
also known as ‘water tablets’. Furosemide tablets are used in the
treatment of oedema (fluid
retention) caused by disorders of the heart, kidneys or liver alone or
in combination with
other anti-hypertensive agents. The tablets may also be used to treat
pulmonary oedema
(build up of fluid in the lungs) and mild to moderate hypertension
(high blood pressure).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FUROSEMIDE TABLETS
DO NOT TAKE FUROSEMIDE TABLETS IF:
• you are allergic(hypersensitive) to Furosemide or any of the other
ingredients in the tablets
(these are listed in section 6) Signs of an allergic reaction include:
a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue.
• you are allergic to amiloride, sulfonamides or sulphonamide
derivatives, such as
sulfadiazine or co-trimoxazole.
• you have been told that you have a low blood volume of fluid in
yo

Summary of Product characteristics

Health Products Regulatory Authority
21 October 2019
CRN008YDQ
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Furosemide Bristol 40 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg of Furosemide.
Excipient(s):
Each tablet contains 105 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Round, white to off-white tablet embossed ‘F 40’ on one side
(‘F’and ‘40’ separated by scoreline) and ‘’BL’’ on the
other side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Furosemide is a potent diuretic with rapid action.
Furosemide tablets are indicated for:
1) The treatment of fluid retention associated with heart failure,
including left ventricular failure, cirrhosis of the liver and renal
disease, including nephrotic syndrome.
2) The treatment of mild to moderate hypertension (alone, or in
combination with other antihypertensive agents in the
treatment of more severe cases).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
It is recommended that Furosemide tablets are taken on an empty
stomach, and with plenty of liquid.
Adults:The initial adult dose is 40mg daily, reduced to 20mg daily or
40mg on alternative days. In some patients daily doses of
80mg or higher (given in divided doses) may be required.
Children: Contra-indicated (see section 4.3)
Elderly: Caution is advised as furosemide is eliminated more slowly in
elderly patients.Treatment should be started with 20mg
and titrated upwards as required (see section 4.4).
Method of Administration:
For oral administration
4.3 CONTRAINDICATIONS
• Hypersensitivity to furosemide or any of the excipients of this
product.
• Hypersensitivity to amiloride, sulphonamides or sulphonamide
derivatives (because of cross-sensitivity between
sulphonamides and furosemide).
• Hypovolaemia or dehydration (with or without accompanying
hypotension) (see se